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Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia

NCT02281500 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-03-31

Study results available
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Summary

The main objective of this study was to evaluate the pharmacokinetics (PK), efficacy, and safety of human plasma-derived fibrinogen concentrate FIB Grifols after a single-dose 70 milligrams/kilogram (mg/kg) body weight administration.

Conditions

  • Congenital Afibrinogenemia

Interventions

BIOLOGICAL

Human Plasma-Derived Fibrinogen Concentrate

A sterile freeze-dried fibrinogen concentrate filled in vials containing 1 g of FIB Grifols. FIB Grifols contains 20 mg/ml of active substance fibrinogen when reconstituted.

Sponsors & Collaborators

  • Instituto Grifols, S.A.

    collaborator INDUSTRY

  • Grifols Therapeutics LLC

    lead INDUSTRY

Principal Investigators

  • Flora Peyvandi, MD · Centro Emofilia & Trombosi Angelo Bianchi Bonomi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-22
Primary Completion
2019-11-11
Completion
2019-11-11
FDA Drug
Yes

Countries

  • United States
  • India
  • Italy
  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02281500 on ClinicalTrials.gov